# K162476: Varian High Energy Linear Accelerator

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Dec 12, 2016 after 97 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913119 (1991). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131807: High Energy Linear Accelerator, Varian Medical Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K181404: Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (2018), 0 descendants of its own

## Indications for use
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K162476
Methodology: https://510kreport.com/methodology